Endurant CHevAr New Indication Trial: ENCHANT

Covidien

Status: Active, not recruiting

Conditions: AAA - Abdominal Aortic Aneurysm

Treatments: Device: Endurant Chimney Graft Technique

Study type: Observational

Funder types: Industry

Identifiers

NCT03320252

MDT16022

Details and patient eligibility

About

The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is ≥18 years old
• Subject is scheduled for primary treatment of the juxtarenal aortic aneurysm with a short infrarenal neck (i.e. no revision subjects)
• Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements
• Subject has provided written informed consent
• Subject is an eligible candidate according to the currently available Endurant II/IIs instructions for use for ChEVAR
• Subject has a juxtarenal aortic aneurysm with a short infrarenal neck (definition of juxtarenal aortic aneurysm with a short infrarenal neck will be in accordance with commercially available Endurant II/IIs instructions for use for ChEVAR).

Exclusion criteria

• Subject is participating in a concurrent study which may confound study results

• Subject has a life expectancy ≤ 2 year

• Subject has an aneurysm that is:

  • Suprarenal or pararenal
  • Isolated iliofemoral
  • Mycotic
  • Inflammatory
  • Pseudoaneurysm

• Subject requires emergent aneurysm treatment, for example, trauma or rupture

• Subject has previously undergone surgical treatment for abdominal aortic aneurysm

• Subject is a female of childbearing potential in whom pregnancy cannot be excluded

• Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment

• Subject has a creatinine level >2.0 mg/dl (or >176.8 μmol/L) and/or is on dialysis

• Subject has an active COVID-19 infection or relevant history of COVID-19. Relevant history of COVID-19 is defined as availability of a positive COVID-19 test with sequela or hospitalization for treatment of COVID-19. Subjects with a positive COVID-19 test who were asymptomatic or had mild symptoms should be excluded only if the positive test was less than 6 months prior to enrollment